FDA-Device2025-03-19Class II
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Philips Medical Systems Nederland B.V.
Hazard
Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement.
Sold states
Domestic: MN
Affected count
1 unit
Manufactured in
Veenpluis 6, Best, Netherlands
Products
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1324-2025Don't want to check this manually?
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